LEWISVILLE, Texas--(BUSINESS WIRE)--
Orthofix International N.V. (NASDAQ:OFIX), a diversified, global medical
device company, today announced results of a cellular study designed to
determine how pulsed electromagnetic field (PEMF) therapy affects gene
expression of intervertebral discs (IVD) cells in normal and
inflammatory environments. Published online in The
Spine Journal, results indicate PEMF therapy may
reduce cellular inflammation and degradation associated with disc
degeneration in human IVD cells.
"The results of this study are clinically important as they demonstrate
PEMF has disease modifying activities that may, in the future, provide a
minimally-invasive solution for patients living with painful
degenerative disc disease," said Dr. Jeffrey C. Lotz, Ph.D., Professor
and Vice Chair of Research, at the UCSF Department of Orthopaedic
Surgery, and co-author of the journal article. "While an important first
step, more studies are needed to determine if this is indeed a viable
option for managing inflammation and impaired healing associated with
painful intervertebral discs."
In an in-vitro human cell culture and microarray gene expression study,
cells were stimulated to elicit the inflammatory environment associated
with degenerative disc disease (DDD). The cells were exposed to the
Orthofix Physio-Stim® PEMF for four hours daily. At day four,
this study revealed that cells treated with PEMF showed a reduction in
proinflammatory markers and a decrease in degeneration of the cellular
matrix relative to the control group, although this reduction did not
persist to day seven.
"We continue to support preclinical evaluation of PEMF technology to
confirm and validate the potential for new clinical applications," said
Orthofix Chief Scientific Officer and co-author James Ryaby, Ph.D. "We
remain committed to furthering the body of clinical evidence that drives
best medical practice and improved patient outcomes. We believe this
study suggests that PEMF may be an important future treatment option for
patients suffering from degenerative disc disease."
Intervertebral disc degeneration is one of the most common mechanical
causes of chronic low back pain. It occurs when the usually rubbery
discs lose integrity as a normal process of aging. In 2010, low back
pain was ranked as the third most burdensome condition in terms of
mortality or poor health in the U.S. by the National
Institutes for Health.
The Orthofix Physio-Stim and Cervical-Stim®PEMF
technology is approved by the U.S. Food and Drug Administration (FDA).
These devices generate a uniform, low-level electrical field that helps
activate and augment the body's natural healing process to enhance bone
fusion.
The paper "Pulsed electromagnetic field (PEMF) treatment reduces
expression of genes associated with disc degeneration in human
intervertebral disc cells" was authored by Stephanie L. Miller, Dezba G.
Coughlin, Erik I. Waldorff, James T. Ryaby, Jeffrey C. Lotz, and
published online in The Spine Journal (2016). To receive a full
copy of the paper, please contact the newsroom@elsevier.com.
The
Spine Journal, the official journal of the North American
Spine Society, is an international and multidisciplinary journal that
publishes original, peer-reviewed articles on research and treatment
related to the spine and spine care, including basic science and
clinical investigations.
About Orthofix
Orthofix International N.V. is a diversified, global medical device
company focused on improving patients' lives by providing superior
reconstructive and regenerative orthopedic and spine solutions to
physicians worldwide. Headquartered in Lewisville, Texas, the Company
has four strategic business units that include BioStim, Biologics,
Extremity Fixation and Spine Fixation. Orthofix products are widely
distributed via the Company's sales representatives, distributors and
its subsidiaries. In addition, Orthofix is collaborating on research and
development activities with leading clinical organizations such as the
Musculoskeletal Transplant Foundation and the Texas Scottish Rite
Hospital for Children. For more information, please visit www.orthofix.com.
Forward-Looking Statements
This communication contains certain forward-looking statements under the
Private Securities Litigation Reform Act of 1995. These forward-looking
statements, which may include, but are not limited to, statements
concerning the projections, financial condition, results of operations
and businesses of Orthofix and its subsidiaries, are based on
management's current expectations and estimates and involve risks and
uncertainties that could cause actual results or outcomes to differ
materially from those contemplated by the forward-looking statements.
Factors that could cause or contribute to such differences may include,
but are not limited to, those risks described in the "Risk Factors"
section of our Annual Report on Form 10-K for the fiscal year ended
December 31, 2014, as well as in other reports that we file in the future
The forward-looking statements in this release do not constitute
guarantees or promises of future performance. Existing and prospective
investors are cautioned not to place undue reliance on these
forward-looking statements, which speak only as of the date hereof. The
Company undertakes no obligation to update or revise the information
contained in this press release.
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Orthofix International N.V.
Investor Relations
Mark Quick,
214-937-2924
markquick@orthofix.com
or
Media
Relations
Denise Landry, 214-937-2529
deniselandry@orthofix.com
Source: Orthofix International N.V.
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